Device
RCDS-CART is a polypropylene (PP) cartridge containing Sodium Bicarbonate Powder (NaHCO3 USP). The device is indicated for use in patients undergoing extracorporeal bicarbonate hem...
Manufacturer
Renal Care Dialysis Solutions, S.A. de C.V.
Renal Care Dialysis Solutions, S.A. de C.V.
Model: 900g
Catalog: 900g
DI: 07506493000129
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Description
RCDS-CART is a polypropylene (PP) cartridge containing Sodium Bicarbonate Powder (NaHCO3 USP). The device is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute renal failure or acute intoxication with dialyzable substances. It is intended to be used as one component in the preparation of dialysate according to a physician's prescription in a 3-stream proportioning machine. Designed for use with a 1:44 concentrate (45X).
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
6c0464a1-ddc1-4ea7-b24a-4e26044235fa
Distribution Status:
In Commercial Distribution
DUNS Number:
951578357
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
07506493000129
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Pkg Type:
CASE
Item #2 - Device ID:
17506493000065
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
10
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
07506493000129
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 35849
Name: Haemodialysis concentrate
Definition:
A product intended to be mixed with water to prepare a solution with an electrolyte composition similar to that of blood (i.e., a dialysate) for the exchange of solutes with blood through a semi-permeable membrane in the dialyser of a haemodialysis system. It is intended to remove metabolic waste from the blood to help maintain physiological blood electrolyte and pH levels. The product typically includes glucose and salts of the following constituents: sodium, potassium, magnesium, calcium, chloride, and anions of weak acids [e.g., bicarbonate (HCO3), acetate, citrate]. It is supplied as a solution or a dry powder. After application, this device cannot be reused.
FDA Product Codes
KPO
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)